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Certolizumab pegol

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Topics: CCG commissioned new medicinesCertolizumab pegolMusculo-skeletal disorders · New MedicinesPatent expiriesSafety in BreastfeedingStability outside the fridge ·
Contents
  1. dm+d
  2. Refrigerated Storage
    1. Cimzia · UCB Pharma
  3. Lactation Safety Information
    1. For rheumatoid arthritis
    2. For psoriasis

dm+d

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Refrigerated Storage

CimziaUCB Pharma

UCB Pharma
Cimzia
200mg solution for injection in pre-filled syringe/pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:
The pre-filled pens/pre-filled syringes may be stored at room temperature (up to 25°C) for a single period of up to a maximum of 10 days.

If the product has been left outside of the fridge and if the next scheduled dose is within 10 days after the start of the storage above 8°C, the product should be left outside of the fridge (at a temperature of up to 25°C) and injected according to the dosing schedule. If the next scheduled dose is more than 10 days after the start of the storage above 8°C, the pack may be returned to the fridge. Once the product has been returned to the fridge it cannot be subjected to further temperature excursions.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

No if exposed to conditions described above
17 October 2022
London MI Service

Lactation Safety Information

For rheumatoid arthritis

For rheumatoid arthritis
Yes
See summary
Moderate amount of published evidence of safety indicates negligible amounts in breast milk which are likely to be degraded in the infant’s GI tract
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
15 September 2019
Bibliography

For psoriasis

For psoriasis
Yes
Topical psoriasis preparation / corticosteroid if appropriate
Moderate amount of published evidence of safety indicates negligible amounts in breast milk which are likely to be degraded in the infant’s GI tract
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
Safety in Lactation: Systemic preparations for eczema and psoriasis
16 September 2019
Bibliography